Hopefully we see the results from the FDA meeting soon as it is stated in the march 8 ann as “The meeting, scheduled for early May”. Not too sure what to expect of the meeting myself but it seems that it will most likely be positive to some extent due to the nature of the discussion.
“face-to-face meeting with the US Food and Drug Administration (FDA) to discuss its unique technology and proposed clinical and regulatory pathway for its lead synthetic antibiotic compound RECCE® 327.”
Some sort of time frame around planned Phase 1 clinical trials would be excellent as it is a topic being discussed.
“The invitation is an outcome of Recce’s recent additional technical data submission, which included a number of questions to the FDA relating to Recce’s proposed regulatory pathway of RECCE® 327, including a Phase 1 clinical trial and beyond.”
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Accelerated Approval for RECCE® 327, page-4
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